K250802
- 510(k) number
- K250802
- Device name
- STERRAD® 100NX Sterilizer with ALLClear Technology (10104)
- Applicant
- Advanced Sterilization Products, Inc. CA · US
- Product code
- MLR — Sterilizer, Chemical
- Decision date
- 2025-04-14
- Date received
- 2025-03-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K250802.pdf
Official FDA record: K250802
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.